SAPROPTERIN DIHYDROCHLORIDE Drug Patent Profile

When do Sapropterin Dihydrochloride patents expire, and when can generic versions of Sapropterin Dihydrochloride launch?

Sapropterin Dihydrochloride is a drug marketed by Annora Pharma, Dr Reddys, and Endo Operations. and is included in eight NDAs.

The generic ingredient in SAPROPTERIN DIHYDROCHLORIDE is sapropterin dihydrochloride. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sapropterin Dihydrochloride

A generic version of SAPROPTERIN DIHYDROCHLORIDE was approved as sapropterin dihydrochloride by ENDO OPERATIONS on May 10^th, 2019.

Summary for SAPROPTERIN DIHYDROCHLORIDE

US Patents:	0
Applicants:	3
NDAs:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	38
Patent Applications:	169
Drug Prices:	Drug price information for SAPROPTERIN DIHYDROCHLORIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SAPROPTERIN DIHYDROCHLORIDE
What excipients (inactive ingredients) are in SAPROPTERIN DIHYDROCHLORIDE?	SAPROPTERIN DIHYDROCHLORIDE excipients list
DailyMed Link:	SAPROPTERIN DIHYDROCHLORIDE at DailyMed

See drug prices for SAPROPTERIN DIHYDROCHLORIDE

Recent Clinical Trials for SAPROPTERIN DIHYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
West China Hospital	Phase 1
Ira Fox	Phase 1/Phase 2
West China Second University Hospital	Phase 2

See all SAPROPTERIN DIHYDROCHLORIDE clinical trials

Pharmacology for SAPROPTERIN DIHYDROCHLORIDE

Drug Class	Phenylalanine Hydroxylase Activator
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors Phenylalanine Hydroxylase Activators

Anatomical Therapeutic Chemical (ATC) Classes for SAPROPTERIN DIHYDROCHLORIDE

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for SAPROPTERIN DIHYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KUVAN	Powder for Oral Solution	sapropterin dihydrochloride	500 mg per packet	205065	1	2017-02-23
KUVAN	Powder for Oral Solution	sapropterin dihydrochloride	100 mg per packet	205065	1	2015-11-09
KUVAN	Tablets	sapropterin dihydrochloride	100 mg	022181	1	2014-06-05

US Patents and Regulatory Information for SAPROPTERIN DIHYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420-001	Aug 18, 2022	AB	RX	No	No
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	TABLET;ORAL	215534-001	Aug 23, 2022	AB	RX	No	No
Dr Reddys	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215798-001	May 13, 2022	AB	RX	No	No
Dr Reddys	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	TABLET;ORAL	207685-001	Jun 15, 2021	AB	RX	No	No
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420-002	Aug 18, 2022	AB	RX	No	No
Dr Reddys	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	209452-001	Mar 30, 2021	AB	RX	No	No